BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUNHO EM T PEQ C/ENC-HEX

    MDR report key: 15121379 · Received July 28, 2022

    Report

    Report Number
    8030965-2022-05344
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Date of Event
    June 30, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    UDI-DI
    07611819377806
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. POSTAL CODE: (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY THE PRODUCT WAS RETURNED TO DEPUY SYNTHESE FOR EVALUATION. THE DEPUY SYNTHESE TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL INSPECTION: THE T-HANDLE HXC-SMALL (P/N: 03.507.000) REVEALED THE SLEEVE IS LOOSE NO DIMENSIONAL INSPECTION WAS PERFORMED FOR THE PUNHO EM T PEQ C/ENC-HEX .A FUNCTIONAL ASSESSMENT WAS PERFORMED WITH THE COMPLAINT DEVICE. THE COMPLAINT DEVICE SLEEVE COMPONENT IS LOOSE AND JIGGLES WHEN MOVED. THE COMPLAINT CONDITION CAN BE REPLICATED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE PUNHO EM T PEQ C/ENC-HEX WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW PART NUMBER: 03.507.000, LOT NUMBER: T174593: A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN ORIF FOR TREATING CHEEK BONE FRACTURE ON (B)(6) 2022. AFTER THE SURGEON MADE A BURR HOLE WITH THE HANDLE AND THE REDUCTION TOOL, REDUCTION WAS ATTEMPTED IN THE LESION. NEXT, HE TRIED TO EXTRACT THE HANDLE AND THE REDUCTION TOOL FROM THE BURR HOLE. HOWEVER, THE REDUCTION TOOL DID NOT TURN WHILE ONLY THE HANDLE TURNED IDLY. HE TOOK TROUBLESHOOTING AND FINALLY MANAGED TO EXTRACT THEM LESS THAN 30-MINUTE SURGICAL DELAY. ACCORDING TO THE SURGEON, HE USED A PLIER TO EXTRACT THE DEVICES DURING THE TROUBLESHOOTING. THE USE OF THE PLIER LEFT SOME SCRATCHES ON THE REDUCTION TOOL¿S TAPPING. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) PUNHO EM T PEQ C/ENC-HEX. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2941533 PUNHO EM T PEQ C/ENC-HEX SCREWDRIVER HXX SYNTHES GMBH T174593 07611819377806

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown